Table 3.

AEs occurring in ≥10% of patients or grade ≥3 AEs occurring in ≥2% of patients regardless of attribution in the safety population

AE, n (%)All-grade AEs (N = 60)Grade ≥3 AEs (N = 60)
Total number of patients with at least one AE60 (100.0)30 (50.0)
Total number of AEs90169
Diarrhea42 (70.0)7 (11.7)
Nausea27 (45.0)
Fatigue25 (41.7)
Decreased appetite19 (31.7)1 (1.7)
Mucosal inflammation17 (28.3)2 (3.3)
Dry skin16 (26.7)
Rash15 (25.0)1 (1.7)
Dyspepsia14 (23.3)
Colitis13 (21.7)8 (13.3)
Hyperglycemia13 (21.7)4 (6.7)
Asthenia12 (20.0)2 (3.3)
Abdominal pain11 (18.3)
Stomatitis11 (18.3)
Back pain10 (16.7)1 (1.7)
Cough10 (16.7)
Headache10 (16.7)
Arthralgia9 (15.0)
Insomnia9 (15.0)
Dyspnea8 (13.3)
Urinary tract infection8 (13.3)
Alopecia7 (11.7)
Dizziness7 (11.7)
Dysgeusia7 (11.7)
Muscle spasms7 (11.7)
Constipation6 (10.0)
Dry mouth6 (10.0)
Gastroesophageal reflux disease6 (10.0)
Hypokalemia6 (10.0)1 (1.7)
Musculoskeletal pain6 (10.0)
Pyrexia6 (10.0)
Vomiting6 (10.0)
Weight decreased6 (10.0)
Aspartate aminotransferase increased5 (8.3)2 (3.3)
Rash maculopapular5 (8.3)2 (3.3)
Pneumonia4 (6.7)3 (5.0)
Hyponatremia2 (3.3)2 (3.3)
  • NOTE: All AE categories are preferred terms, encoded using MedDRA version 20.0. For frequency counts by preferred term, multiple occurrences of the same AE in an individual are counted once. For the total number of events, multiple occurrences of the same AE in an individual were counted separately.